Home / Recalls / Helena Laboratories, Corp. / Z-1244-2022

Z-1244-2022 Class II Ongoing

Recalled by Helena Laboratories, Corp. — Beaumont, TX

Recall Details

Product Type
Devices
Report Date
June 15, 2022
Initiation Date
April 6, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
51 kits

Product Description

V8 Immunodisplacement Kit REF 1803

Reason for Recall

Due to microbial growth causing interference with interpretation.

Distribution Pattern

U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,

Code Information

Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803

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